BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY

    K Number: K880544 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    0
    Applicant Total
    13
    Review Days
    52

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    Basic Information

    Device Name
    WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
    K Number
    K880544
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Wescor, Inc.
    Date Received
    February 9, 1988
    Decision Date
    April 1, 1988
    Product Code
    GJL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GJL Romanowsky Stains

    Other Clearances by Wescor, Inc.

    K Number Device Name
    K121823 CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
    K010031 NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
    K863395 WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
    K881592 WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
    K881512 WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
    K853973 WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
    K834214 WESCOR 5500 VAPOR PRESSURE OSMOMETER
    K834208 COLLOID OSMOMETER 4400
    K840472 SYS MACRODUCT SWEAT COLLECTION SYS 3600
    K833295 WESCOR 7100 AEROSPRAY SLIDE STAINER
    Search all 13 clearances from Wescor, Inc. →